Is Biolinq Shine FDA approved or cleared?
Yes. Biolinq Shine by Biolinq Incorporated is named in the FDA register with a De Novo authorisation, first authorised in 2025, latest decision in 2026.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Biolinq Shine |
|---|---|
| Maker | Biolinq Incorporated |
| Care area | Diabetes & metabolism |
| What it does | Needle-free wearable glucose microsensor that shows time in range with a light, no app or fingerstick |
| FDA | De Novo, latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | biolinq.com |
| Status | FDA verified |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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